ElectroCore’s non-invasive vagus nerve (nVNS) stimulation therapy shown to be safe and to produce no meaningful cardiac adverse effects
Posted: 28 April 2015 |
Open-label trial shows electroCore’s nVNS therapy does not cause any meaningful cardiovascular adverse effects in patients with asthma…
A poster presentation at the 67th American Academy of Neurology has shown that electroCore’s non-invasive vagus nerve stimulation (nVNS) therapy does not cause any meaningful cardiovascular adverse effects in patients with asthma.
The poster presentation reported on the cardiac effects of nVNS in asthma patients using nVNS to treat acute bronchospasm. This study further reinforces the safety of nVNS shown in other clinical trials1 and experience with more than 1500 patients.
The open-label trial which was carried out at four centres across the US involved 284 ECGs being performed on 29 patients with a history of mild-to-moderate asthma. Each patient had a 12-lead electrocardiograms (ECGs) performed at three study visits: baseline, stimulation, and follow-up. During the stimulation visit, ECGs were performed prior to, during, and ≤90 minutes after administration of a single 120-second VNS stimulation.
Treatment with nVNS had no meaningful effect on heart rate
The results showed that there were no clinically significant ECG changes, either in isolated readings or in comparison to baseline. Treatment with nVNS had no meaningful effect on heart rate, PR interval, corrected QT interval, or QRS duration. These findings were reviewed by an independent cardiologist.
The gammaCore treatment, which is self-administered by the patient for 120 seconds at home or anywhere else, involves placing the small, hand-held device on the skin of the neck over the vagus nerve.
ElectroCore, which is presently seeking FDA approval for the treatment and prevention of cluster headache, currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the EU, South Africa, India, New Zealand, Australia, Colombia, Brazil and Canada.
- A twelve-month open-label study in the March 2015 issue of the journal Neurology led by Professor Peter Goadsby conducted at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.
